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VBCR - April 2015, Volume 4, No 2 - FDA News & Updates
Alice Goodman

Patients with chronic painful osteoarthritis (OA) may have a new pain killer if phase 3 clinical trials turn out to be positive. The drug in question, called tanezumab, has had a checkered history. At first, several trials showed that it was remarkably effective in people with OA, allowing them to resume activities they had not been able to participate in. Then adverse events were reported, including joint destruction and potential effects on the nervous system. Some experts, however, thought the increase in joint destruction was due to the patients’ feeling so good while taking tanezu­mab that they were dancing and playing sports that further degraded the joints.

Beginning in 2010, the US Food and Drug Administration (FDA) halted various clinical trials of tanezumab and other drugs in its class—nerve growth factor (NGF) protein receptor blockers. Although trials in OA were halted, trials of tanezumab and other NGF receptor blockers continued for terminal cancer pain.

On March 24, 2015, it was announced that the FDA was lifting the ban on tanezumab studies in OA after a review of nonclinical data characterizing the sympathetic nervous system response to tanezumab. Now that the ban has been lifted, late-stage clinical trials in OA will continue.

Nearly 20% of the US population has chronic pain, and safe and effective treatment of the condition is an unmet need. NSAIDs are commonly used to mask pain but are associated with a constellation of side effects. Tanezu­mab, a monoclonal antibody that blocks the NGF protein, represents a novel approach to chronic pain. It is estimated that the FDA approval of tanezumab would lead to sales of $100 million in the year 2020 (Cowen and Company estimate). If the drug is approved for other pain conditions, including terminal cancer pain and diabetic neuropathy, sales could be even higher.

Tanezumab is being co-developed by Pfizer, Inc, and Eli Lilly.

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Last modified: June 26, 2015
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